3

Attest
Biological Monitoring System
Technical Product Profile

A Technical Service Publication

Table of Contents
Introduction ......................................................................... 5
Product Description ............................................................ 5
Indicators ......................................................................................... 5
Test Frequency ................................................................................ 8
Usage of Test Packs ........................................................................ 8
Instructions for Use ........................................................................ 11
Use of Controls .............................................................................. 12
Incubators ...................................................................................... 13
Troubleshooting Guide .................................................................. 15
Resistance Data ............................................................................. 17
Subculturing Techniques ............................................................... 17
Storage and Shelf Life ................................................................... 18
Disposal ......................................................................................... 18
References ..................................................................................... 19
Addendum ..................................................................................... 20

Introduction
The Attest biological monitoring system is a convenient, reliable
system for monitoring steam sterilization. This biological monitoring
system has been a routine component of the quality assurance program
of thousands of hospitals for two decades.
Biological indicators and an incubator make up the Attest system.
The unique self-contained design of biological indicator makes it easy
to use, easy to read, and provides reliable results. These indicators may
be incubated within the dental office or may be sent to a microbiology
lab for incubation and interpretation.

Product Description
Indicators

The Attest indicator system includes two separate biological indicators, each constructed to ensure optimal reliability in the quality assurance program of any healthcare facility. All Attest indicators are selfcontained (i.e., contain both the dry spore strip and the growth medium). This design eliminates the possibility of contamination which
may occur with spore strips in glassine envelopes when they are transferred to the growth medium. Also, the one spore per vial design provides information about the incubation and sterilization process that
may not be obtainable with a two spore per vial design.1
Attest indicators are used routinely in steam sterilizers and are an
important, practical part of any healthcare facilitys quality assurance
program.
The Attest monitoring system meets all the biological monitoring
requirements suggested by the American Dental Association (ADA)2,
the Association for the Advancement of Medical Instrumentation
(AAMI)3,4, Joint Commission on Accreditation of Healthcare Organizations (JCAHO)5, Association of Operating Room Nurses (AORN)6,
American Society for Healthcare Central Service Personnel
(ASHCSP)7, the U.S. Military (Standard No. 969)8 and the Centers for
Disease Control (CDC)9.
The entire Attest system is color coded for quick reference and easy use.

Color
Coding
Brown

Blue

Sterilization
Process Monitored

Attest
Indicators

Attest Incubators
110/120 volt

Attest Incubators
220/240 volt

Steam (except
270F/132C
gravity displacement)

1262P

Model 116 (14 vials)

133 3F (56 2C)

Model 118 (14 vials)

130 3F (56 2C)

Steam, gravity
displacement
270F/132C

1261P

see above

see above

This product profile pertains to the Attest biological indicator system

that requires 24-48 hours incubation.

Steam Indicators (Catalog numbers 1261P, 1262P) have the

following components:

1. Dry spore strips containing spores of Bacillus stearothermophilus

(derived from ATCC 7953) with a minimum population of 1 105
spores per strip.
2. Growth medium contained in a crushable glass ampule. This medium is modified Tryptic Soy broth with a pH-sensitive indicator
dye (bromocresol purple).
3. A flexible polypropylene vial to hold both the dry strip and the
medium ampule.
4. A blue (1261P) or brown (1262P) polypropylene cap containing a
coated hydrophobic filter which is a sterilant-permeable bacterial
barrier.
5. A label bearing the date of manufacture of the Attest indicator
and a process chemical indicator that turns from rose to brown when
processed. Space is provided to record test data.
NOTE: Do

not use to monitor dry heat, chemical vapor (MDT

Harvey chemiclave) or ethylene oxide (EO) sterilization processes.

Biological Indicators and Test Packs for

Steam Sterilization Monitoring

Load

30

Gravity

Pulsing
Prevacuum

Pulsing

250-254F
(121-123C)
or
270-274F
(132-135C)

20

Unwrapped
Hard Goods

1262P

Brown

Gravity

1262P

Brown

10

Gravity

1261P

Blue

250-254F
(121-123C)

< 15

Gravity

1262P

Brown

Unwrapped
Hard Goods

270-274F
(132-135C)

Gravity

1261P

Blue

Unwrapped
Hard Goods

270-274F
(132-135C)

Prevacuum
Pulsing

1262P

Brown

Wrapped
Hard Goods

1262P Indicator

Attest Steam
Incubator

Attest
Air Removal Biological
Attest
Temperature Time (min) Method
Indicator Cap Color
250-254F
(121-123C)
or
270-274F
(132-135C)
or
285-287F
(141-143C)

Packs
Containing
Fabric

1261P Attest biological indicators were designed to monitor 270F/

132C gravity flash steam sterilization processes. Special spore strip
placement and cap design on the 1261P Attest biological indicator
provide a more representative challenge to the 270F/132C gravity
displacement steam sterilization cycle.

1262P Attest biological indicators were designed to monitor 250F/

121C gravity, 270F/132C prevacuum, or pulsing-steam sterilization
processes.

Test
Frequency

For optimal sterilization quality assurance it is recommended that

Attest biological indicators be used in test packs to monitor each load
of steam sterilized supplies. (See Addendum for further details).
Testing with biological monitors should be done at least weekly in most
dental practices.2, 9

Usage of
Test Packs

For optimal quality assurance of the sterilization process, an Attest

biological indicator should be used to monitor every load of steam
sterilized supplies. The Attest biological indicator should be placed in
a test pack that is representative of the load being processed and one
that creates the greatest challenge to the sterilization process.10
Steam Cycles

Steam test packs are designed to create a challenge to the steam sterilization process.
1. Unwrapped hard goods
a. 250-254F (121-123C) for 15 minutes or more in a gravity
displacement cycle.
Place a 1262P Attest biological indicator in an unwrapped
basin, tray, or any unwrapped metal item that is representative of the load being sterilized.
b. 270-274F (132-135C) for 3 minutes or more in a gravity
cycle (e.g., flash cycle).
Place a 1261P Attest biological indicator in an unwrapped
instrument tray with a representative number and type of
instruments normally processed. AAMI suggests placing a
biological indicator in an empty instrument tray.11
c. 270-274F (132-135C) for 3 minutes or more in a pulsing
or prevacuum cycle.

Place a 1262P Attest biological indicator in a representative unwrapped hard goods item (e.g., instrument tray) from
the sterilizer load.
2. Wrapped hard goods
a. 250-254F (121-123C) for 20 minutes in a gravity displacement cycle.
Place a 1262P Attest biological indicator in the center of a
representative wrapped hard goods pack (e.g., instrument
set) from the sterilizer load. Sacrifice the pack to retrieve the
biological indicator.
b. 270-274F (132-135C) for 10 minutes in a gravity displacement cycle.
Place a 1261P Attest biological indicator in the center of a
representative wrapped hard goods pack (e.g., basin or
instrument set) from the sterilizer load. Sacrifice the pack to
retrieve the biological indicator.
c. 270-274F (132-135C) for 3 minutes or more in a pulsing
or prevacuum cycle.
Place a 1262P Attest biological indicator in the center of a
representative wrapped hard goods pack (e.g., basin or
instrument set) from the sterilizer load. Sacrifice the pack to
retrieve the biological indicator.
3. Fabric packs containing goods run at 250-254 F (121-123C)
for 30 minutes or more in a gravity displacement cycle, at 270274F (132-135C) for 3 minutes or more in a pulsing or
prevacuum cycle, or 285-287F (141-143C) for 2 minutes or
more in a pulsing cycle.
a. Place a 1262P Attest biological indicator between two
small packs from the sterilizer load which, taken together,
approximate the largest and most dense pack in that load.
Overwrap the packs and label as a test pack. After processing, the indicator can be retrieved without sacrificing
the goods.
b. Place a 1262P Attest biological indicator in the center of
an actual pack from the sterilizer load which is representative of the goods contained in that load (e.g., a linen pack for
a load of linens, a tray for loads which include metal instruments, etc.). Place the 1262 Attest biological indicator in
the center of the pack. Sacrifice the pack to retrieve the
biological indicator.

10

The 1261P Attest biological indicator may be placed

in a tray or container of medical devices going directly to
patient use to ensure that the medical devices are properly
sterilized. Remember to aseptically transfer the contents of the
tray or container to the sterile field before removing the biological indicator for incubation.
NOTE:

See Instructions For Use section for further details.

Validation Testing

Validation testing should be performed on an ongoing basis to periodically evaluate products routinely sterilized.12,13
AAMI states that Product testing should always be done when major
changes are made in packaging, product or load configuration, or
materials, such as dimensional changes, weight changes, or changes
in the type of packaging or wrapper used.14
It is also recommended that validation testing be done quarterly, after
sterilizer installation, any major redesign or relocation of a sterilizer,
or after suspected malfunction or major repair.15 The facility should
run three consecutive cycles resulting in negative biological indicators
before the sterilizer is put back into use.
To do validation testing, place multiple 1261P, 1262P Attest biological indicators and chemical indicators in the areas of the packaging and load that create the greatest challenge to air removal and
steam, or humidity penetration. Do repetitive and thorough testing to
determine the sterilization process parameters needed to produce
consistent negative biological indicators and chemical indicators with
complete end point color changes. The product or sterilizer should not
be used until biological indicators are routinely negative.16
Validation testing determines the sterilization process parameters
needed to produce a sterile medical device when changes are made.
Routine testing ensures that sterilization process parameters determined during validation testing are being met on a regular basis. See
Instructions For Use for further details on how to use Attest
monitoring products.
Interpretation of Results

1. Examine the indicator at regular intervals (e.g., 8, 12, 18, 24

and 48 hours) for any color change. Appearance of a yellow
color (a positive readout) indicates bacterial growth. No color
change indicates an adequate sterilization process.
2. Act on any positive test as soon as the first evidence of growth
is noted, even if only one Attest biological indicator shows a
positive when two or more were used in the sterilization cycle.

Always retest the sterilization process by placing several test

packs containing Attest biological indicators throughout the
test load. Attest biological indicators can be subcultured if
identification of positive growth is desired (See Disposal for
further details).
3. The recommended incubation time for 1261P Attest biological indicators is 24 hours. The recommended incubation time for
1262P Attest biological indicators is 48 hours. A final
determination of sterility can be made after these stated
incubation times.
4. Record results (log books are available).

Instructions
for Use

Choose the appropriate biological indicator, and test pack configuration

for the sterilization process being used.
1262P Attest biological indicators for steam sterilization.

1. Identify the indicator by noting the sterilizer and load numbers,

and the processing date on the label.
2. Place a 1262P Attest biological indicator in a suitable test
pack which is representative of the load. See Usage of Test Packs
for further details.
3. Place the test pack in a full load in the area most challenging for
the sterilant. In a steam sterilizer this is generally on the bottom
shelf, near the door, and over the drain.
4. Process the load as usual.
5. After the completion of the cycle and while wearing safety
glasses and gloves, fully open the sterilizer door for a minimum
of 5 minutes prior to removing the Attest biological Indicator.
Warning: Crushing or excessive handling of the biological
indicators before cooling may cause the glass ampule to burst
which may result in personal injury from flying debris. 3M
recommends the use of safety glasses and gloves when removing biological indicators from the sterilizer. Safety glasses should
also be worn when crushing biological indicators.

6. Retrieve the Attest biological indicator from the test pack.

7. Check the chemical indicator on the label for a color change
from rose to brown.
8. Incubate the biological indicator within two hours or refrigerate
it until incubation is possible. (If these instructions are not
followed the spores will die off at room temperature and a

11

sterilization failure may go undetected.)17 The incubator temperature is 133 3F (56 2C).

12

1261P Attest biological indicators for 270F/132C gravity

displacement steam sterilization.

1. Identify the indicator by noting the sterilizer and load numbers,

and the processing date on the label.
2. Place a 1261P Attest biological indicator in a suitable tray
which is representative of the load. See Usage of Test Packs for
further details.
3. Place the tray (e.g., perforated instrument tray with representative instruments on the bottom shelf, near the door, and over the
drain) in an otherwise empty load.
4. Process the load as usual.
5. After the completion of the cycle and while wearing safety
glasses and gloves, fully open the sterilizer door for a minimum
of 5 minutes prior to removing the Attest biological Indicator.
Warning: Crushing or excessive handling of the biological
indicators before cooling may cause the glass ampule to burst
which may result in personal injury from flying debris. 3M
recommends the use of safety glasses and gloves when removing biological indicators from the sterilizer. Safety glasses should
also be worn when crushing biological indicators.

6. Retrieve the Attest biological indicator from the test tray.

7. Check the chemical indicator on the label for a color change
from rose to brown.
8. Incubate the biological indicator within two hours or refrigerate
it until incubation is possible. (If these instructions are not
followed the spores will die off at room temperature and a
sterilization failure may go undetected.)18 The incubator temperature is 133 3F (56 2C).

Use of Controls

As a positive growth control, place a non-sterilized Attest biological

indicator in each incubator each day Attest indicators are used. This
control must be of the same lot and manufacturing date as the test
biological indicators used that day. The purpose of this control is to ensure:

correct incubation conditions

viability of indicators (Incorrect storage conditions could adversely

affect even those indicators which are within their stated shelf life.)

capability of medium to promote rapid growth.

When examining the processed indicator at regular intervals such as 8,

12, 18, 24 and 48 hours, also examine the control indicator for a color
change toward yellow (evidence of bacterial growth). Record results and
discard indicators in accordance with your healthcare facilitys policy.
The Attest monitoring system provides separate color coded vials for
steam indicators. This one spore per vial system provides the user with
the best assurance of sterility. If both indicator organisms are on the
same spore strip (e.g., as in a two spores per vial system), a positive
growth control could be obtained if incorrect incubation conditions
existed (e.g., incubator not functioning, or vials inadvertantly incubated
at wrong temperature). If the test biological indicator came from a cycle
with a sterilization process failure, a false positive control and false
negative test would result.19

Incubators The Attest system offers a dry block incubator. Each Attest incubator is pre-set at the appropriate temperature to promote growth of the
test organism. The incubators internal temperatures are rigidly controlled and automatically maintained.
Attest incubators provide optimal conditions for the accurate read-out
of the Attest indicators. The growth of each test organism is temperature dependent, it is critical that the Attest indicators be used with the
Attest incubator. The system is color-coded for quick, easy identification.
Attest dry block incubators with a 14-vial capacity are available for
both steam indicators (No. 116 which operates at 110/120 volts and No.
118 which operates at 220/240 volts).
Do not add water to these incubators.
Incubation

Attest System for Steam

Attest Indicator

Cap Color

Incubation time

1261P

Blue

24 hours

1262P

Brown

48 hours

13

14

Instructions for Incubation use

1. Position indicator in metal block (See Figure 1). Place the

bottom of the indicator into the incubators metal heating block
so that the indicator is at an angle of approximately 45.
Figure 1

2. Push the indicator straight back (See Figure 2). This crushes the
ampule and activates the indicator.
Figure 2

3. Push the activated indicator down to seat it in the metal heating

block (See Figure 3). Be sure that the cap remains above the
metal block when you push the indicator down.
Figure 3

Troubleshooting
Guide

Any positive biological indicator must be considered evidence of an

inadequate sterilization process. This evidence must not be ignored, or
regarded as a false positive test.
Action

1. Retrieve and reprocess all goods run in that sterilizer dating

from the last negative biological indicator.20
2. Rechallenge the sterilizer with several biological indicators
placed in appropriate test packs or trays throughout the load.
3. The sterilizers in question should not be returned to regular
service until the results of this retesting are all satisfactory (i.e.,
negative).
Potential Causes of Sterilization Failure21,22,23

It must be remembered that sterilization is a process; a deficiency in

any of the variables necessary to effect sterilization can result in
nonsterile product. These variables include:

sterilizer performance

sterilant quality and quantity

choice of packaging materials

packaging technique

sterilizer loading techniques

inappropriate cycle parameters for the items being processed.

Checklists of potential causes of steam sterilization failure follow.

Steam Sterilization

The parameters needed for steam sterilization are time, temperature and
saturated steam. A steam sterilization process failure can be caused by
poor steam quality and/or inadequate steam quantity, equipment malfunction and human error.

Poor steam quality and/or inadequate steam quantity, caused by:

1. Wet steam
inadequate trap in steam line
steam contact with a cold load
steam pressure too high for the temperature

15

16

2.

Superheated steam
improper chamber heat up
desiccated packaging materials
steam pressure too low for the temperature

3. Variations in steam pressure due to clogged filters, poorly

engineered piping or excessive demands.
4. Out-of-calibration pressure gauges and controllers.
a. Incomplete air removal
plugged drain screen
clogged vent lines
faulty vacuum pump
inadequate door gasket seal
low steam pressure
plugged, faulty or maladjusted control valves
come up time less than 1.5 minutes
b. Inadequate cycle temperature
temperature gauge out of calibration
long heat-up time of large loads (heat lag)
variations in steam pressure due to clogged filters,
poorly engineered piping or excessive demands on
the steam supply
c. Insufficient time at temperature
timer gauge out of calibration
inappropriate cycle parameters for the load being
processed
come up time less than 1.5 minutes
d. Human error
inadequately cleaned items preventing steam
penetration
packaging materials impermeable to steam
packs too large or too dense for the cycle parameters
poor loading techniques that entrap air and prevent
steam penetration
incorrect operation of sterilizer
entire load inadvertently not processed

Resistance
Data

Biological indicators must provide an adequate challenge to the sterilization process. The resistance of a biological indicator to the mode of
sterilization can be defined by several methods. A common resistance
measurement is survival/kill data. Survival/kill data establishes the time
frame for indicator resistance under a specific set of test conditions: i.e.,
all indicators must survive the given survival time and all must be
killed by the given kill time.
Survival/kill data for Attest biological indicators outside of test
packs is:
Attest
Indicator

Subculturing
Techniques

Test
Conditions

Survived

Kill

1261P

Saturated steam @ 270F (132C)

gravity displacement (Flash)
sterilization with 1.5 minute come
up time

1 min

3 min.

1262P

Saturated steam @ 250F

(121C), gravity displacement
sterilization

5 min

15 min.

1262P

Saturated steam @ 270F

(132C), prevacuum sterilization

1 min

3 min.

If the healthcare facilitys policy requires subculturing of all positive

biological indicators it is important to subculture the Attest biological
indicator as soon as it turns positive (preferably within 24 hours after
the indicator is incubated). If more than 24 hours pass, the bacteria may
die off because of the acid produced during the growth process and
viable bacteria will be undetectable.
The procedure for subculturing should first be tried on a positive control to allow the laboratory to become familiar with the subculturing
method.
An outline of the subculturing procedure follows. These steps are
designed to minimize the chance of contamination.
1. Carry the Attest biological indicator in an upright position to
the laboratory for evaluation.
2. In a clean area (laminar air flow hood), carefully remove the
Attest biological indicator cap with a twisting motion and then,
with a sterile pipette, aseptically remove the contents of the vial.
3. Place one drop of media on a slide and perform a gram stain.
4. Deposit the remaining contents of the pipette into sterile Soybean Casein Digest Broth (SCDB).

17

5. Incubate the broth at a temperature of 133 3F (56 2C) for

1261P or 1262P Attest biological indicators. It is critical that
the correct temperature be used to ensure the growth of B.
stearothermophilus (1261P or 1262P Attest biological
indicators).

18

6. A bacterial isolation can then be performed by streaking a

loopful of the SCDB growth onto prepared Soybean Casein
Digest Agar (SCDA) plates and incubate at the appropriate
temperature.
7. Perform a gram stain from the growth obtained on the SCDA
plate. Also, additional biochemical and morphological determinations can be made to conf irm the presence of B. stearothermophilus ATCC 7953 or (An Attest Subculturing Reference Sheet is available from 3M Technical Service.)
8. The gram stain should show gram positive rods.

Storage and Store Attest biological indicators at normal room conditions: 59-86F
Shelf Life (15-30C), 35-60% relative humidity.
Do not store these indicators near sterilants or other chemicals.
Attest biological indicators have a 2-year shelf life from the date of
manufacture. The manufacturing date is printed on the label of each
biological indicator, and on each box of Attest biological indicators.

Disposal

Dispose of used Attest biological indicators in accordance with your

healthcare facilitys policy. You may wish to autoclave any positive
indicators at 250F (121C) for at least 15 minutes, at 270F (132C)
for 10 minutes in a gravity steam sterilizer, or at 4 minutes in a pulsing
or prevacuum steam sterilizer.

References

1. Biological Monitoring: Does your system tell you all you need
to know? 3M Infection Control Rounds, March, 1987, pp. 1-4.
2. Council on Dental Materials. Instruments and Equipment;
Council on Dental Therapeutics; Council on Dental Research;
Council on Dental Practice. Infection control recommendations
for the dental office and the dental laboratory. J Am Dent Assoc
(Supplement) 1992.
3. Good Hospital Practice: Steam Sterilization and Sterility Assurance, AAMI, 1988, pp. 13-15.
4. Good Hospital Practice: Steam Sterilization Using the Unwrapped Method (Flash Sterilization), AAMI, 1985, pp. 7-8.
5. Joint Commission on Accreditation of Healthcare Organizations,
Scoring Guidelines for Infection Control, 1990.
6. Recommended Practices, Sterilization and Disinfection, AORN,
February, Vol. 54, No. 3, 1987, pp. 444-446.
7. Recommended Practice for Central Service, Sterilization,
American Society for Healthcare Central Service Personnel of
the American Hospital Association, Section 6, 1989, pp. 6-19,
28-32.
8. Biological Indicators for Sterilization Processes, Military
Standard, MIL-STD-969, January 15, 1980, pp. 1-9.
9. Recommended Infection Control Practices for Dentistry,
MMWR, May 28, 1993, Vol. 42, No. RR-8, p. 5.
10. Test Packs: An Integral Part of the Sterilization Process, 3M
Infection Control Rounds, First Quarter, 1988, pp. 1-4.
11. Good Hospital Practice: Steam Sterilization Using the Unwrapped Method (Flash Sterilization), AAMI, 1985, pp. 7-8.
12. Selection and use of Chemical Indicators for Steam Sterilization
Monitoring in Health Care Facilities, AAMI, TIR, No. 3, pp.
35-37.
13. Good Hospital Practice: Steam Sterilization and Sterility Assurance, AAMI, 1988, pp. 16-17.
14. Ibid.
15. Recommended Practices, Sterilization and Disinfection, AORN,
February, Vol. 54, No. 3, 1987, p. 444.
16. Selection and Use of Chemical Indicators for Steam Sterilization Monitoring in Health Care Facilities, AAMI, TIR, No. 3,
1988, p. 37.

19

20

17. Caputo, RA Rohn, KJ: Mascoli, CC: Recovery of biological

indicator organisms after sublethal sterilization treatment.
Journal of the Parental Drug Association, September-October,
Vol. 34, No. 5, 1980, pp. 394-397.
18. Caputo, RA, Rohn, KJ, Mascoli, CC: Recovery of biological
indicator organisms after sublethal sterlization treatment. Journal of the Parenteral Drug Association, September - October,
Vol. 34, No. 5, 1980, pp. 394-397.
19. Biological Monitoring: Does your system tell you all you need
to know. 3M Infection Control Rounds, March 1987, pp. 1-4.
20. Good Hospital Practice: Steam Sterilization and Sterility Assurance, AAMI, 1988, p. 15.
21. Selection and Use of Chemical Indicators for Steam Sterilization Monitoring in Health Care Facilities, AAMI, TIR No. 3,
1988, pp. 5-13.
22. Chemical Indicators: Rationale For Use: 3M Infection Control
Rounds, 1st Quarter, 1989, pp. 1-5.
23. Perkins, JJ: Principles and Methods of Sterilization, ed 2 (1969),
Springfield, IL, Charles C. Thomas, 7th printing, 1982, pp. 95192.

Addendum

21

Organizations Recommendations on Biological Indicators

Quarantine Until
Biological Results
Available?

Organization

Biological Indicator
Requirements

Frequency of Use
Steam

AAMI 1
Good Hospital Practice:
Steam Sterilization &
Sterility Assurance, 1988

Should be used inside a

16 towel or 12" x 12" x
20" hetergeneous test
pack.

At least weekly, preferably

daily, each load that
contains an implantable
devices.

Implantable objects if
possible.

Should perform a
presumptive
identification. of the
microorganism.

Good Hospital Practice:

Steam Sterilization Using
the Unwrapped Method
(Flash Sterilization), 1986

Should be used in a
perforated or mesh bottom
tray.

At least once a week (do

not flash implantables).

A presumptive
Identification. should
be performed.

ADA 2
Should be placed in packs,
Infection control recommen- bags or tray.
dation for the dental office
& the dental laboratory, 1992.

Weekly

ASHCSP
Recommended Practice
for Central Service,
Sterilization, Oct. 1989

Should be used inside a 16

towel pack for steam.

At least once a day, each

load of implantable items.

Implantable items until BI

results are available

AORN 3
Recommended
Practices/Sterilization,
and Disinfection, 1990

Should be used in
a 12" 12" 20"
hetergeneous test pack
for steam .

Weekly and as needed;

each load containing
implantables.

Implantable objects until

BI is negative at 48 hours.

Army
Army Regulations
(AR40-19), 1984

Shall be used

Minimum of once weekly.

CDC 4
Recommendedd Infection
Practices for Dentistry, 1993

Should be used

At least once a week.

JCAHO 5
Scoring Guidelines, 1988

Are used

At least weekly, or with

each load if sterilization
activities are performed
less frequently. It is
recommended that such
test be performed daily and
each load of implantables
of intravascular material.

Implantable or
intravascular material.

VA6
VA Manual 61, MP-2,
1985 and MP-2,
Subchapter E, Change
159, June 22, 1983

Must be used in a 12" x 12"

x 20" heterogeneous test
pack.

Daily. Each
load of implantable or
intravascular materials.

Implantable or
Should do a presumptive
intravascular materials
identification.
until spore test is negative
at 48 hours.

1.

AAMIAssociation for the Advancement of Medical Instrumentation

2.

ADA American Dental Association

3.

AORNAssociation of Operating Room Nurses

4.

CDCCenters for Disease Control

5.

JCAHOJoint Commission on Accreditation of Healthcare Organizations.

6.

VAVeterans Administration

Harvey Chemiclave is a trademark of MDT.

Attest is a trademark of 3M.

3M, 1993

Subculture Positive
BIs?

H..I. 4509

22

3
Dental Products Laboratory
3M Center, Building 260-2B-13
St. Paul, MN 55144-1000

Printed in U. S. A.
1994 3M